PainNCT02107456
Effect of Dry Needling on Myofascial Trigger Point
A study testing Dry Needling in people with Pain, run by University of Social Welfare and Rehabilitation Science at 1 site in Iran.
Trial summary
Myofascial trigger point is one of the most common causes of musculoskeletal disorders. Myofascial trigger point in upper trapezius has been reported as a symptom in patients with neck and upper thoracic pain. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Pain
- What is being tested?
- Dry Needling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteIran
- Study dates
- Jul 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Presence of a palpable taut band in muscle.
- 2. Presence of a hypersensitive tender spot in the taut band.
- 3. Reproduction of the typical referred pain pattern of the MTP in response to compression. To detect active TrPs, TrP pressure tolerance was assessed using a mechanical pressure algometer. The investigator applied continuous pressure with the algometer with an approximate pressure of 2.5 kg/cm2.
- 4. Spontaneous presence of the typical referred pain pattern and/or patient recognition of the referred pain as familiar.
- 5- Pain of at least 30 mm on a visual analogue scale (VAS). The selected MTP of the UT muscle was located in the middle of the more nearly horizontal fibers of the UT 40.
Who cannot join
- had a history of fibromyalgia syndrome, whiplash injury, cervical spine surgery and fracture, cervical radiculopathy, having therapy within the past month before the study
- any systematic disease such as rheumatism and tuberculosis or cervical myelopathy, multiple sclerosis
- local infection,
- pregnancy
- taking anticoagulants (e.g. warfarin)
- long-term steroid using
Trial locations and contacts
1 site in 1 country.
Iran1 site
University of Social Welfare and Rehabilitation Sciences
Tehran, Tehran Province, 1985713831
About this study
Official title: The Long Term Effect of Dry Needling on Myofascial Trigger Point in the Upper Trapezius Muscle.
Myofascial trigger point is one of the most common causes of musculoskeletal disorders. Myofascial trigger point in upper trapezius has been reported as a symptom in patients with neck and upper thoracic pain. The purpose of this study was to investigate the prolonged effect of dry needling on myofascial trigger point in upper trapezius muscle.
Read the detailed description
Pain intensity and Disability of arm, hand and shoulder (DASH) were collected at base line and at the end of treatment sessions, two weeks and three months follow up in both groups.
- Conditions
- Pain
- Being tested
- Dry Needling
- Keywords
- Dry Needling, Myofascial trigger point, Upper trapezius
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingDevice
Also called Western Accupuncture
Dry needling was performed for one week, three times a week.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling | Experimental | The taut band of trigger point in upper trapezius muscle; localized between the thumb and index finger, was needled forward and backward repeatedly until there were no more local twitch response Receives: Device: Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity using visual analogue scale (VAS) were collected at base line and at the end of treatment.
Measured: One year
Secondary outcomes (1)
Disability
Disability of Arm and Shoulder was collected at base line and at the end of treatment.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startJul 2012
- Primary completionFeb 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Social Welfare and Rehabilitation Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Massoud Arab, University of Social Welfare and Rehabilitation Science
- Investigators
- Amir M Arab, PhD, Principal investigator, University of Social Welfare and Rehabilitation Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107456
- Sponsor's protocol ID
- 920114
- Status last verified
- Apr 2014
- First submitted
- 3 Apr 2014
- Last updated
- 8 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long Term Effect of Dry Needling on Myofascial Trigger Point in the Upper Trapezius Muscle.
- ClinicalTrials.gov ID
- NCT02107456
- Acronym / sponsor ID
- 920114
- Conditions
- Pain
- Keywords
- Dry Needling, Myofascial trigger point, Upper trapezius
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Social Welfare and Rehabilitation ScienceUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Myofascial trigger point is one of the most common causes of musculoskeletal disorders. Myofascial trigger point in upper trapezius has been reported as a symptom in patients with neck and upper thoracic pain. The purpose of this study was to investigate the prolonged effect of dry needling on myofascial trigger point in upper trapezius muscle.
Detailed description
Pain intensity and Disability of arm, hand and shoulder (DASH) were collected at base line and at the end of treatment sessions, two weeks and three months follow up in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dry Needling | Experimental | Device: Dry NeedlingThe taut band of trigger point in upper trapezius muscle; localized between the thumb and index finger, was needled forward and backward repeatedly until there were no more local twitch response |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. Presence of a palpable taut band in muscle.
- 2. Presence of a hypersensitive tender spot in the taut band.
- 3. Reproduction of the typical referred pain pattern of the MTP in response to compression. To detect active TrPs, TrP pressure tolerance was assessed using a mechanical pressure algometer. The investigator applied continuous pressure with the algometer with an approximate pressure of 2.5 kg/cm2.
- 4. Spontaneous presence of the typical referred pain pattern and/or patient recognition of the referred pain as familiar.
- 5- Pain of at least 30 mm on a visual analogue scale (VAS). The selected MTP of the UT muscle was located in the middle of the more nearly horizontal fibers of the UT 40.
Key exclusion criteria (6 listed)
- had a history of fibromyalgia syndrome, whiplash injury, cervical spine surgery and fracture, cervical radiculopathy, having therapy within the past month before the study
- any systematic disease such as rheumatism and tuberculosis or cervical myelopathy, multiple sclerosis
- local infection,
- pregnancy
- taking anticoagulants (e.g. warfarin)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry NeedlingAlso: Western AccupunctureDry needling was performed for one week, three times a week. | Device | Dry Needling |
Primary outcome
Pain intensity
Time frame: One year
Pain intensity using visual analogue scale (VAS) were collected at base line and at the end of treatment.
1 secondary outcome
Disability
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir M Arab, PhD principal investigator
University of Social Welfare and Rehabilitation Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling in people with Pain, run by University of Social Welfare and Rehabilitation Science at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2014.